Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

Breast Cancer Clinical Trial

Official title:

Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702858
• Other study ID #: Blue Citrus BC-AIT-001
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: August 27, 2013
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2013
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).

Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.

Description:

Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level >40

2. Patient complaints of musculoskeletal symptoms

3. Currently taking AIT for ER positive postmenopausal breast cancer

Exclusion Criteria:

1. Previously taken Blue Citrus

2. Presence of bone metastasis

3. Unable to complete VAS Pain Scale

4. Unable to comply/complete SF 12 Quality of Life survey

5. Plan to discontinue AIT in less then six months

6. Unable to complete ADL scale

7. Have diagnosis of fibromyalgia

8. Have diagnosis of rheumatoid arthritis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Joint Pain

Intervention

Drug:
• Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
• Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo		6 months	Yes
Secondary	Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo		6 months	Yes
Secondary	Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living		6 months	Yes